Status:
COMPLETED
Phase II Study to Evaluate the Efficacy of AMG 317
Lead Sponsor:
Amgen
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline...
Eligibility Criteria
Inclusion
- Males or females 18 to 65 years of age at the time of screening
- Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening
- At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening
- If receiving allergen immunotherapy, a stable dose for \> 3 months before screening and anticipated to remain stable for the duration of the study
- Positive to skin prick or RAST
- Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points
- Nonsmoker or ex-smoker with \< 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago
Exclusion
- Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months
- History of endotracheal intubation for asthma-related exacerbation within 3 years of screening
- Respiratory illness within 4 weeks of screening
- History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
- Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit.
- Leukotriene antagonists within 2 weeks before first run-in visit
- Oral or parenteral corticosteroids within 6 weeks before first run-in visit
- Live/attenuated vaccinations within 4 weeks of screening or during the study
- Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT00436670
Start Date
March 1 2007
End Date
February 1 2009
Last Update
March 23 2016
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